Vitamin D & Vitamin A

Vitamin D and vitamin A reference formula at a default of 10 mcg (400 IU) and 10,000 IU per serving, developed as a softgel or tablet.

Vitamin D & Vitamin A is a reference formula for brands building a two-vitamin fat-soluble product around 10 mcg (400 IU) of vitamin D and 10,000 IU of vitamin A per serving. The brand sets the final amounts for its market. Reference labels span vitamin D from 3 to 40 mcg and vitamin A from 600 to 25,000 IU or from 360 mcg to 3 mg, so the amounts differ widely between products and markets.

Softgel is the lead format because both vitamins dissolve in oil, with tablet developed alongside from dry beadlet forms. The work centers on the vitamin A: its form, its unit of measure and its upper intake level shape the specification more than the vitamin D does.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Vitamin D10 mcg (400 IU)Vitamin D3 (cholecalciferol), oil concentrate for softgels and dry beadlet for tablets; 10 mcg vitamin D per servingVitamin D2, a different form with its own specification
Vitamin A10,000 IUVitamin A palmitate (retinyl palmitate), oil concentrate for softgels and dry beadlet for tablets; 10,000 IU per servingBeta-carotene as provitamin A, set as a separate specification and not converted to the retinol amount

Vitamin D is stated in both units: 10 mcg equals 400 IU at 40 IU per mcg, the conversion used in the FDA 2019 guidance and consistent with the paired values in the NIH ODS fact sheet. Vitamin A is stated in IU as on the reference label and is not converted to mcg here, because the conversion depends on the form (retinol or provitamin carotenoids), which is set in formulation.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around fat-soluble vitamin nutrition. Vitamin D and vitamin A are included together because they are frequently paired in oil-based softgels.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Skeletal nutritionVitamin DThe Institute of Medicine committee concluded that the evidence supports a key role of calcium and vitamin D in skeletal health and set a vitamin D RDA of 600 IU per day for ages 1 to 70 [1]. Evidence: Referenced
Vitamin A nutritionVitamin AA review describes vitamin A as a group of vital micronutrients present in the diet, with retinyl esters in animal products and provitamin carotenoids in vegetables and fruits, that the body converts into active forms such as retinol, retinal and retinoic acid [2]. Evidence: Referenced

The amounts are examples. The same committee found the evidence for extraskeletal outcomes inconsistent and insufficient to inform nutritional requirements [1]; the reports in [1] and [2] do not test this formula, so any claim on a finished product is reviewed for each market.

Available Formats

Reference labels are mostly softgels, with tablets and capsules behind them; softgel and tablet are developed here.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Softgel1 softgelVitamin D 10 mcg (400 IU), vitamin A 10,000 IU90 or 180 softgelsGelatin or plant-based shell, glycerin, purified water, soybean or corn oilLead format; both vitamins in oil
Tablet1 tabletVitamin D 10 mcg (400 IU), vitamin A 10,000 IU100 or 200 tabletsMicrocrystalline cellulose, silica, magnesium stearateDry beadlets; light and oxygen protection needed

Raw Material Input & Fill (Design Estimate)

Design estimates. The inputs assume commercial potencies of 1,000,000 IU per gram for the vitamin D3 oil concentrate and 1,700,000 IU per gram for the vitamin A palmitate oil, and 100,000 IU per gram and 250,000 IU per gram for the dry beadlets; these potencies are assumptions to be replaced by the supplier’s certificate.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
SoftgelVitamin D3 oil 0.4 mg, vitamin A palmitate oil 5.9 mg300 mg fillabout 294 mg of carrier oilPotency of both vitamins after encapsulation, peroxide value, fill weight spread, shell integrity
TabletVitamin D3 beadlet 4 mg, vitamin A palmitate beadlet 40 mg200 mg tablet weight156 mgContent uniformity of a few milligrams of actives, hardness, assay after a light and humidity hold

Liquid and gummy are separate projects, because vitamin A at this level needs its own stability work in water-based and sugar-based systems.

Formulation Considerations

Vitamin A form and level. Preformed vitamin A and provitamin A carotenoids behave differently on the label, in assay and in regulation. The specification names the form, and the level is checked against the upper intake level that applies to preformed vitamin A in each sales market.
Two units. The label combines vitamin D in mcg and IU with vitamin A in IU. The specification and the label copy state each ingredient in one agreed unit, with the conversion shown only for vitamin D.
Oxidation and light. Both vitamins degrade with oxygen, light and heat. Antioxidants such as tocopherol, nitrogen flushing during filling and opaque packaging are decided in formulation.
Potency overage. Vitamin potency falls over the shelf life, and an overage is commonly added at manufacture. The overage is set from stability data and stated against the label amount.

Customization Options

Brands adjust the amounts, the vitamin A form, the format and the add-ons.

ParameterRangeNote
Vitamin D per serving10, 25 or 50 mcg (400, 1000 or 2000 IU)Examples for the brand; converted at 40 IU per mcg
Vitamin A per serving1,250, 5,000 or 10,000 IUExamples for the brand; level depends on the market
Vitamin A formRetinyl palmitate or beta-caroteneDifferent specifications; not converted to each other
FormatSoftgel or tabletLiquid and gummy are separate projects
Add-onsVitamin K2, calciumA third ingredient changes the fill weight and the claim wording

The pilot run confirms the potency of both vitamins after encapsulation, softgel fill and seal, and the assay after a short light and heat hold.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (Vitamin D 10 mcg (400 IU) + Vitamin A 10000 IU on the label of CF000653; example DSLD labels 4340, 4896, 8482). The label names the two vitamins by name; vitamin D3 and retinyl palmitate are set as the forms.
SpecificationSet in formulationVitamin D3 at 10 mcg and vitamin A palmitate at 10,000 IU per serving; potency of each vitamin, peroxide value, microbial and heavy-metal limits and method are fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Ross AC, Manson JE, Abrams SA, et al. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011;96(1):53-8. DOI · PubMed<br>[2] Carazo A, Macáková K, Matoušová K, et al. Vitamin A Update: Forms, Sources, Kinetics, Detection, Function, Deficiency, Therapeutic Use and Toxicity. Nutrients. 2021;13(5):1703. DOI · PubMed

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